Kornimate/medical-research-clean huggingface dataset:
a study of tas-116 in patients with solid tumors

Conditions: Advanced Solid Tumors

Summary: a first-in-human (fih) study of tas-116 in patients with advanced solid tumors was first initiated in japan in april 2014 and has been ongoing since then. the study consists of a dose escalation phase and a dose expansion phase. three dosing regimens of tas-116, once daily (qd), every other day (qod) and 5 days on/2 days off regimens in 21-day cycles, are being evaluated. this phase i study is also planned to enroll patients with advanced solid tumors in uk to confirm the mtd, safety, tolerability, and pharmacokinetics of tas-116 in a western patient population in the dose expansion phase. in addition, patients with her2+ mbc, nsclc harboring egfr mutations or nsclc harbouring alk translocations will be further evaluated for safety, tolerability, and efficacy in 3 separate cohorts at recommended dose of tas-116 on the 5 days on/2 days off regimen.


Eligibility criteria:
inclusion criteria: 1. male or females with an age ≥ 18 years (≥ 20 years in japan) 2. patients with histological- or cytological-confirmed, advanced unresectable breast, gastric, or non-small cell lung cancer, who have progressed on (or not been able to tolerate) standard therapy or for whom no standard anticancer therapy exists. a. part c: only the following subtype of tumors with the molecular/genetic alterations will be enrolled: her2 positive mbc advanced nsclc, harboring egfr mutations after progression on osimertinib advanced nsclc, harboring alk translocations after treatment with alectinib or at least 2 alk inhibitors 3. has at least one measurable lesion as defined by recist criteria 4. is able to take medications orally (e.g., no feeding tube). 5. is able to agree to and sign informed consent and to comply with the protocol 6. has adequate organ function exclusion criteria: 1. has a serious illness or medical condition(s) 2. has received treatment with any prescribed treatments within specified time frames prior to study drug administration 3. significant ophthalmologic abnormality, 4. impaired cardiac function or clinically significant cardiac disease

Keywords: phase i solid tumors pharmacokinetics pharmacodynamics mtd tas116 hsp90 inhibitor neoplasms her2 positive mbc nsclc egfr nsclc alk positive
gasless single-port laparoscopic-assisted radical resection for rectal carcinoma

Conditions: Laparoscopic Surgery

Summary: this project aims to investigate the safety and effectiveness of gasless single-port laparoscopic-assisted radical resection (gslr) in the treatment of rectal carcinoma.

the gasless single-port laparoscopic-assisted surgery (gsls) is associated with rapid recovery and shorter postoperative hospital stay and no pneumoperitoneum complications occur after the operation. to our knowledge, there have been no reports about gsls applied to the treatment of gastrointestinal cancer in the world. to explore the safety and effectiveness of gsls in rectal cancer patients, this project plans to evaluate the operation time, cardio-pulmonary function, postoperative pain, immunologic function and restoration of bowel function after the operation.

Eligibility criteria:
inclusion criteria: * rectal carcinoma;the distance between tumor and anal verge is 5-15cm; the primary tumor can radical resect. exclusion criteria: * neoadjuvant therapy;surgical contraindication.

Keywords: gasless single-port laparoscopic surgery;rectal carcinoma
gliflozins on hf in regurgitant rheumatic heart

Conditions: Rheumatic Heart Disease; Heart Failure

Summary: the objective of this trial is to detect impact of gliflozin on patients with heart failure due to reurgitant rheumatic valve disease

* rheumatic heart disease is a chronic sequel of acute rheumatic fever caused by group a β hemolytic streptococcal pharyngitis and possibly pyoderma, which mimics molecular heart structures so the immune response leads to carditis and valvular heart damage. damage to valves cause mitral and/or aortic regurgitation, or in long-standing stenosis. complications of rheumatic heart disease include heart failure, embolic stroke, endocarditis and atrial fibrillation . * heart failure (hf) is a progressive syndrome characterised by the inability of the heart to provide adequate blood supply to meet the metabolic demand of different tissues . * the recent esc/aha/acc guidelines of hf set medications as class 1 for the hf therapy as ace-i/ arni/beta-blocker/mra/ sglt2 i as they reduced the risk of cardiovascular death and worsening hf in patients with hfref , unless contraindicated or not tolerated. * empagliflozin is an orally available inhibitor sodium glucose co-transporter 2 receptor (sglt-2), empagliflozin exerts its effect by preventing sodium and glucose reabsorption from proximal convoluted tubules. this leads to increased urinary sodium and glucose excretion, this is associated with a modest osmotic diuresis, blood pressure lowering effect, improvement in arterial stiffness , and decrease in heart rate. * dapa-hf trial shows: the primary outcome of cardiovascular death, hf hospitalization, for dapagliflozin vs. placebo, was 16.3% vs 21.2% (p \< 0.001). * empa-reg outcome trial shows: the primary outcome, cardiovascular death or hf hospitalization, for empagliflozin vs. placebo, was 19.4% vs. 24.7% ( p \< 0.001).

Eligibility criteria:
inclusion criteria: * all male or female patients having rheumatic heart disease with either mitral, aortic, tricuspid regurge as a single or combined valvular lesion * patients aged 18 years or older at time of inclusion in the study * patients with hf currently in nyha class ii-iv, or asymptomatic patients with proved mitral regurgitant lesion. * body mass index (bmi) \< 45 kg/m2 exclusion criteria: * advanced stage liver and kidney failure (glomerular filtration rate \< 20 ml/min/1.73 m2). * patient with implanted cardiac pacemaker, implantable cardioverter-defibrillator (icd) or cardiac re-synchronization therapy (crt) or implanted left ventricular assist device (lvad) * diagnosis of cardiomyopathy induced by other etiologies rather than rheumatic heart disease eg, ischemia , dilated cardiomyopathy,.....etc within the 12 months prior to visit 1 * known allergy or hypersensitivity to sglt-2 inhibitors * women who are pregnant, nursing, or who plan to become pregnant while in the trial * ongoing hematological diseases and malignancies
phase ⅱstudy of pinocembrin injection to treat ischemic stroke

Conditions: Ischemic Stroke

Summary: this research is a randomized, double-blind, placebo-controlled, multicenter clinical study. chinese subjects with ischemic stroke.

subjects will randomly enter into one of two groups,the period of treatment is 14 days,follow-up to the 90th days.

Eligibility criteria:
inclusion criteria: * 35-75 hospitalized patients * patients with acute stroke ≤24h * nihss score 6-20 at time of enrollment , the score ≥2 of item 5 and/or 6 * for the first time or always without obvious sequelae of stroke disease(mrs≤1） * informed consent exclusion criteria: * the disease such as acute intracerebral hemorrhage,tumor and encephalitis which cause similar symptoms * patient with nihss level of consciousness score≥2 or dementia,or other patients who the investigator think that don't fit into the study * tia * symptoms of disease rapidly improving during the randomized * severe hypertension(sbp \> 200 mmhg or dbp \>110 mmhg) * inadequate liver function(ast or alt greater than 2 times the upper limit of normal values);renal impairment (creatinine clearance \<60ml/min） * severe system or viscera organic disease * have used other neuroprotectant or other experimental drugs * patient who are unlikely to complete the study that due to a severe clinical condition * pregnant or breast-feeding * participation in a previous clinical study within 30 days * meets all other exclusion criteria

Keywords: pinocembrin for injection placebo mrs
a randomized controlled trial of in-home tele-behavioral health care utilizing behavioral activation for depression

Conditions: Depression

Summary: this study will evaluate the effectiveness of a web-based behavioral activation(ba) treatment for depression by comparing it to in-person ba treatment in soldiers and veterans with major and minor depressive disorder. we will test the hypothesis that 8 sessions of in-home ba delivered via a webcam will be as safe and effective in reducing symptoms of hopelessness and depression as in-person ba treatment for depression.


Eligibility criteria:
inclusion criteria: * current major depressive or minor depressive disorder * high-speed internet/network access at home (384kbs minimum) * informed consent * fluent in the english language exclusion criteria: * currently undergoing psychotherapy for depression * less than 18 or greater than 65 year of age * active psychotic symptoms/disorders as determined by the scid for dsm-iv * dysthymic disorder * current suicidal ideation with intent or recent (within six months) history of a suicide attempt * history of organic mental disorder * current substance dependence as determined by the scid (lifetime substance dependence or substance abuse will not be excluded) * history of violence or poor impulse control causing potential risk to staff or others * significant ongoing stressors that require urgent crisis intervention * having a living arrangement that will not permit the use of a private space to participate in the study

Keywords: depression behavioral activation tele-medicine
the effects of cinnamon on postprandial blood glucose, and insulin in subjects with impaired glucose tolerance

Conditions: Diabetes

Summary: to study the effect of cinnamon on postprandial blood glucose, and plasma concentrations of insulin in subjects with impaired glucose tolerance.

ten subjects with impaired glucose tolerance were assessed in a crossover trial. a standard 75 g oral glucose tolerance test (ogtt) was served with placebo or cinnamon capsules. finger-prick capillary and venous blood samples were taken before and 15, 30, 45, 60, 90, 120, 150, and 180 min after the start of the ogtt to measure glucose, and insulin.

Eligibility criteria:
inclusion criteria: * patients were selected for the study on the basis of the following inclusion criteria: diagnosis of impaired glucose tolerance for \< 12 months before enrollment. glucose tolerance status and fasting blood glucose levels were evaluated using the criteria established by the american diabetes association. exclusion criteria: * subjects who had thyroid disorders, or used insulin, oral hypoglycemics, and insulin-sensitizing drugs within 60 days before enrollment were excluded.
hearing aid transmitter performance study - srf-366

Conditions: Hearing Loss

Summary: sonova hearing systems pass through different development and study stages. at an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. if the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. afterwards, and prior to product launch, the sonova hearing systems undergo a final quality control in terms of clinical trials. this is a confirmatory study, investigating benefits of a modified hearing aid loudspeaker. this will be a clinical investigation which will be conducted mono centric at national acoustic laboratories a well known institution with exceptional experience (australia).

in this study a comparison with two phonak receiver in canal (ric) devices is done. the experimental device with a modified hearing aid loudspeaker concept and the active comparator with the existing technology will be compared regarding speech intelligibility, listening effort and sound quality in speech in noise, quiet situations for people with mild to moderate hearing losses.

Eligibility criteria:
inclusion criteria: * adult hearing impaired persons (minimum age: 18 years, mild to moderate hearing loss) * good written and spoken english language skills * healthy outer ear * ability to fill in a questionnaire (p/ecrf) conscientiously * willingness to wear receiver in canal hearing aids * informed consent as documented by signature * normal cognitive abilities exclusion criteria: * contraindications to the md in this study, e.g. known hypersensitivity or allergy to the investigational product * limited mobility and not in the position to attend weekly appointments in sydney (aus) * limited ability to describe listening impressions/experiences and the use of the hearing aid * inability to produce a reliable hearing test result * known psychological problems

Keywords: acoustical coupling
study to evaluate hemodynamic response to to a sublingual dose of glyceryl trinitrate in subjects receiving ta-1790, sildenafil citrate, and placebo

Conditions: Erectile Dysfunction

Summary: the objective of this study is to evaluate the hemodynamic response to a sublingual dose of glyceryl trinitrate in subjects receiving oral ta-1790, sildenafil citrate, and placebo.


Eligibility criteria:
inclusion criteria: * provide written informed consent * willing to comply with all study requirements and clinic schedules * male between 30 to 60 years of age * non-smoker * no history of alcohol abuse * normal screening laboratory values exclusion criteria: * allergy or hypersensitive to pde5 inhibitors * evidence of clinically significant disease * supine systolic/diastolic blood pressure level * history of cardiovascular disease * previously participated in ta-1790 within the past 30 days
web-based ultra-brief intervention for heavy drinkers trial

Conditions: Alcohol Abuse

Summary: the purpose of the study is to determine whether a web-based ultra-brief intervention, consisting of personalized normative feedback or standardized self-help material, is effective in lowering self reported alcohol use in heavy drinkers.

background and purpose: the danish national board of health has awarded funds for two studies that will test methods that can be used for effective and early detection of heavy drinkers. the study will be carried out in 12 danish municipalities in 2008. the study is part of the 'diet, smoking, alcohol and exercise' nationwide health study of the danish population. it takes place in 13 municipalities in 2007 and 2008. the purpose of the study is to determine whether a web-based ultra-brief intervention, consisting of personalized normative feedback or standardized self-help material, is effective in lowering self reported alcohol use in heavy drinkers. design: the experiment is designed as a randomized controlled trial, where heavy drinkers will be allocated to either: a) an intervention group receiving web-based personalized normative feedback (pfi) b) an intervention group receiving web-based self-help material (shm) c) a control group receiving nothing. after 6 and 12 months there will be follow-up and the participants will receive a questionnaire with questions about their alcohol consumption (internetbased and paper).

Eligibility criteria:
inclusion criteria: * participants must be invited to the danish 'diet, smoking, alcohol and exercise' nationwide health study. * participants must have a weekly alcohol consumption above the recommended danish limits (168 grams of alcohol for women, 252 grams of alcohol for men). exclusion criteria: * weekly alcohol consumption less than 168 grams of alcohol for women and 252 grams of alcohol for men. * participants who have not informed their email address.

Keywords: heavy drinking ultra-brief intervention brief intervention alcohol prevention randomized trial personal normative feedback self-help material web-based intervention studies prevention & control
patients' preference for subcutaneous or vaginal progesterone as luteal support in ivf/icsi cycles

Conditions: Infertility; In Vitro Fertilization

Summary: this randomized, controlled, prospective, crossover, open-label, two-treatments, two-period trial aimed to evaluate the preference expressed by the patient concerning the subcutaneous administration of progesterone versus the vaginal one. the couples, scheduled for performing 2 in vitro fertilization (ivf)/intracytoplasmic sperm injection (icsi) cycles will be randomized to receive, as luteal phase supplementation, pleyris 25 milligram (mg) (a single subcutaneous administration per day) or prometrium 200 mg (3 vaginal administrations per day).

each participant will receive both treatments. during the first ivf/icsi cycle, the luteal phase will be supplemented with subcutaneous progesterone (s) or vaginal progesterone (v). at the end of the cycle (on the day of beta-hcg), a survey for determining the level of satisfaction will be administered and filled in by the patient during the waiting time and always before the knowledge of the result. this practical organization allows the elimination of emotional biases correlated with the outcome. in case of a negative beta-hcg, the patient will be scheduled for a second ivf/icsi cycle after a washout (w) period (between 2 and 6 months). in the second cycle, the patient will undergo, during the luteal phase, the opposite treatment (v or s). also in this case, the survey for evaluating the level of satisfaction will be administered on the day of beta-hcg, with the same modalities of the first cycle. the domains of the surveys are focused on facility of the administration, comfort, level of complaint, side effects, overall level of satisfaction. the sequence s-v or v-s will be randomly assigned (random assignment) with the concealment of the allocation. in case of a negative beta-hcg also in the second cycle, a post-hoc comparison between the two treatments will be carried out through a semantic differential scale, in the "follow-up" phase.

Eligibility criteria:
inclusion criteria: first ivf/icsi attempt (at the enrolment), regular menstrual cycles (25-33 days), controlled ovarian stimulation performed with gonadotropin releasing hormone (gnrh) antagonists and gonadotrophins (recombinant fsh) exclusion criteria: systemic diseases, chronic medical therapies, pregnancy in one of the ivf/icsi cycles, embryo "freeze all" strategy in one of the ivf/icsi cycles for preventing ovarian hyperstimulation syndrome (ohss)

Keywords: progesterone supplementation ivf preference expressed by the patient
study of rivaroxaban use and potential adverse outcomes in routine clinical pratice (netherlands)

Conditions: Venous Thrombosis; Pulmonary Embolism; Atrial Fibrillation; Acute Coronary Syndrome

Summary: this prospective cohort study will provide information about: characteristics of rivaroxaban use in patients who are prescribed rivaroxaban for the first time compared to patients who are prescribed acenocoumarol for the first time, the occurrence of intracranial haemorrhage, gastrointestinal and urogenital bleeding, and the occurrence of non-infective liver disease.


Eligibility criteria:
inclusion criteria: * all male and female patients who have been prescribed for the first time either rivaroxaban or standard of care from the date of market authorization of rivaroxaban to dec 31, 2017 exclusion criteria: * patients who have any record of being dispensed their index drug in the year before index date (i.e. cohort entry), or who qualify for both cohorts on the same day will be excluded

Keywords: rivaroxaban stroke prevention in atrial fibrillation anticoagulants hematologic agents therapeutic uses observational venous thromboembolism secondary prevention of acute coronary syndrome intracranial hemorrhages gastrointestinal hemorrhage
safety and efficacy of pro 542 in the treatment of hiv-infected patients

Conditions: HIV Infections; Acquired Immune Deficiency Syndrome

Summary: the purpose of this study is to determine any adverse effects of pro 542 after administration and to determine the anti-hiv effects of pro 542 in the patient.

a 2 arm study involving a series of 3 triweekly doses of pro 542. one arm will involve patients on a stable dose of anti-retroviral therapy and the other arm will consist of patients not receiving anti-retroviral therapy. three patients will be enrolled in each arm followed by a safety evaluation. following the safety evaluation, 3 more patients may be enrolled in each arm. after the first 12 patients, an additional 12 patients may be enrolled pending safety data.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of hiv * patients must be on a stable dose of acceptable anti-hiv therapy or receiving no anti-hiv therapy for at least four (4) weeks prior to the start of this study * hiv-1 determination by rna-pcr greater than or equal to 100,000 copies/ml * cd4 count \>50/cubic mm at screening exclusion criteria: * patients who have previously received pro 542 * patients with active, significant infection (other than hiv) not controlled by antibiotics * pregnant or lactating women * patients with an estimated life expectancy of \<3 months * patients currently receiving steroids or other immunosuppressive therapy or immunoglobulin therapy except for topical or inhaled steroids * patients with known allergy or hypersensitivity to pro 542 or immunoglobulin preparations

Keywords: treatment experienced
insulin glargine "all to target" trial

Conditions: Diabetes Mellitus, Type 2

Summary: the primary objectives were: * to demonstrate the superiority of lantus plus stepwise addition of mealtime apidra® (lantus/apidra-3) versus twice-daily premixed insulin based on the proportion of patients achieving target glycemic control (as measured by hemoglobin a1c \[hba1c\] \<7.0%) at week 60 * to demonstrate the noninferiority of lantus plus addition of 1 mealtime apidra injection (lantus/apidra-1) versus twice-daily premixed insulin based on the reduction from baseline to week 60 in hba1c


Eligibility criteria:
* male or female patients * 30 to 80 years of age * body mass index \<45 kg/m2 * with type 2 diabetes mellitus for at least 2 years * with an hba1c level at screening of \>7.5% and \>7.0% at randomization * on stable dual or triple oral therapy for at least 3 months * oral agents in 2 or 3 of the following classes: su or repaglinide, biguanide, or tzd, willing and able to perform self-monitoring of bg * females of child-bearing potentially were required to be willing and able to use adequate contraception